China, New Products

Chi-Med, Eli Lilly score a landmark approval in China for the first new cancer drug developed in China

Hutchison China MediTech CEO Christian Hogg just nabbed important bragging rights to the first full approval of a major cancer drug that was made in China and now will be sold in China.

Christian Hogg

Allied with Eli Lilly, Chi-Med says that fruquintinib will be marketed as Elunate for colorectal cancer.

“Elunate is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomized clinical trial in China,” said chairman Simon To. “This is the result of over a dozen years of steadfast commitment by Chi-Med in research and development in China’s emerging biotech ecosystem.”

The data — unveiled at ASCO a little more than a year ago — all lined up in the company’s favor, with an overall survival rate of 9.3 months compared to 6.57 months in the placebo arm. The median progression-free survival rate hit 3.71 months compared to 1.84 months for the control group. While not a radical improvement, the data lines up as approvable. And the partners have high hopes for a global roll out.

Simon To

The approval comes in the wake of some very big, and very quick, OKs for some of the world’s biggest new drug innovations in China. After proving to be an obstacle for many developers, China has completely revamped the approval process in the last couple of years as the country commanded increased attention for the second biggest healthcare market in the world. 

Shanghai-based Chi-Med has taken a high-profile position as a key player in its emerging biotech market.

“China’s time is coming,” Hogg told Reuters. “The biotech infrastructure that has been built in China is very strong and the pool of scientific talent is very deep.”

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,900+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->